Manager of Regulatory Affairs Jobs in Lansing, IL
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Director, Regulatory Affairs Strategy
- Chicago, IL (23 miles from Lansing, IL)
- 5 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 5 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Manager/Senior Manager, Regulatory Affairs - CDx
- Chicago, IL (23 miles from Lansing, IL)
- 16 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 16 days ago
CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of...
Remote Work- Chicago, IL (23 miles from Lansing, IL)
- 18 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 18 days ago
Job Summary This role maintains clinical trial regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits....
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL (23 miles from Lansing, IL)
- 19 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 19 days ago
Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with...
Regulatory Affairs Manager - JR29338-3800
- Chicago, IL (23 miles from Lansing, IL)
- 19 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 19 days ago
Job Summary This role maintains clinical trial regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits....
Regulatory Affairs Manager (Greater Chicago Area, IL)
- Chicago, IL (23 miles from Lansing, IL)
- 22 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 22 days ago
The Regulatory Affairs Manager reports to and assists the Director of Regulatory Affairs and Product Engineering. This Position Supports and assists the Director in formulating Regulatory...
- Chicago, IL (23 miles from Lansing, IL)
- 23 days ago
- Chicago, IL (23 miles from Lansing, IL)
- 23 days ago
Regulatory Affairs Manager II#25-53978 Chicago, IL Fully Remote Job Description 100% Remote (EST time zone) 12 months *** per hour max bill rate Performs eCTD submission management across ***'s...
Remote WorkManager, Regulatory Affairs - Advertising & Promotion
- Chicago, IL (23 miles from Lansing, IL)
- 30+ days ago
- Chicago, IL (23 miles from Lansing, IL)
- 30+ days ago
Overview The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and configuration...
Our client, a full range supplier of automotive coatings market is seeking a Regulatory Affairs Manager to join their team. As a Regulatory Affairs Manager, you will be part of the management team...
Demographic Data for Lansing, IL
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Salary for Manager of Regulatory Affairs Jobs in Lansing, IL
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Lansing, IL offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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